New Psoriasis Medications: 9 Drugs Seeking FDA Approval

The psoriasis treatment landscape continues to evolve. The FDA has approved dozens of new psoriasis medications since the turn of the century alone — with a big focus on biologic medications. Now, multiple targeted therapies are approaching FDA review. 

Beyond the established biologics, newer agents are exploring alternative pathways and dosing strategies that may further refine disease control. 

Below, we review nine psoriasis medications recently approved or in advanced stages of clinical trials. Note that this is not an exhaustive list.

1. Icotrokinra

Icotrokinra (JNJ-2113) is the first oral IL-23 inhibitor for psoriasis. It was approved by the FDA in March 2026 for treatment of moderate-to-severe plaque psoriasis for people ages 12 and older.

In the phase 3 ICONIC clinical trials, icotrokinra met primary endpoints with no new safety signals. Studies also suggest it’s superior to deucravacitinib and may be beneficial for difficult-to-treat scalp and genital psoriasis.

2. Picankibart

Picankibart (IBI112) is an anti IL-23 monoclonal antibody in development for plaque psoriasis. This subcutaneous injection targets interleukin-23 (IL-23). Other IL-23 inhibitors include Skyrizi (risankizumab) and Tremfya (guselkumab).

This injectable medication has shown promising results thus far:

• Up to 86% of people in a phase 2 study achieved at least 90% symptom improvement after 1 year of treatment. 

• In the phase 3 CLEAR study, co-primary endpoints were met with no new safety signals. Responses were maintained with every 12-week dosing after induction.

Next up, researchers will determine if picankibart is effective in patients who did not respond to IL-17 inhibitor treatment. 

Picankibart received approval from China's National Medical Products Administration (NMPA) in late 2025. An FDA approval application may come next.

3. Ebdarokimab

Ebdarokimab (AK 101) is a monoclonal antibody medication that targets both IL-12 and IL-23, similar to Stelara (ustekinumab). It's given as a quarterly subcutaneous injection.

Phase 3 studies at 16 and 52 weeks demonstrated short-term and sustained response in symptom improvement among 80% of participants.

Ebdarokimab finished two phase 3 studies in China, and it won Chinese approval in April 2025. It’s unclear whether its manufacturer intends to apply for FDA approval.

4. Imsidolimab

Imsidolimab (ANB019) is an IL-36 inhibitor in development for treatment of generalized pustular psoriasis (GPP). The FDA has accepted its approval application with a target decision date in late 2026. Currently the only FDA-approved medication for GPP is Spevigo (spesolimab).

Phase 2 GALLOP trial results on efficacy were promising, showing some people experienced an improvement in their symptoms in as little as 3 days. In Phase 3 GEMINI studies, over half of participants reported clear or almost clear skin 4 weeks after a single IV dose (versus 13% placebo). In a follow-up study, 100% of people who continued monthly treatment maintained clear skin.

5. Vunakizumab

Vunakizumab (SHR-1314) is another IL-17 inhibitor injection, similar to Cosentyx (secukinumab) and Taltz (ixekizumab).

According to phase 3 data published in January 2025, vunakizumab is safe and effective for treating moderate-to-severe plaque psoriasis. After 12 weeks (3 months) of treatment, over 70% of people experienced significant skin improvement. These benefits were generally maintained through 1 year of treatment.

Vunakizumab was approved in China in August 2024. Its manufacturer has not submitted a U.S. approval application to the FDA. Vunakizumab is also in development for treatment of psoriatic arthritis.

6. Piclidenoson

Piclidenoson (CF101) is a twice-daily tablet in the works for plaque psoriasis with a unique mechanism of action. It’s a type of A3 adenosine receptor (A3AR) agonist. This molecule inhibits production of inflammatory cytokines and ultimately induces inflammatory cell apoptosis.

So far, phase 3 study data found that piclidenoson was significantly better than placebo at helping people achieve 75% symptom improvement within 4 months of treatment.

Another phase 3 study is now on deck for piclidenoson. The manufacturer is expected to submit an FDA-approval application as its phase 3 trial program matures.

7. Envudeucitinib

Envudeucitinib (previously ESK-001) is another twice-daily oral medication in development for moderate-to-severe plaque psoriasis. It’s a TYK2 inhibitor, similar to Sotyktu (deucravacitinib), but designed to be more selective — potentially improving its effectiveness and safety profile.

The 12-week phase 2 STRIDE study yielded promising results, and ​​the long-term extension results were recently published. More than 60% continued to see improvement for up to 52 weeks of treatment with 40 mg BID.

The ONWARD phase 3 trials are now underway, with data expected in early 2026.

8. ICP-488

ICP-488 is another oral TYK2 inhibitor in development for plaque psoriasis. 

So far, phase 2 trials suggest that ICP-488 significantly reduces psoriasis symptoms for people with moderate-to-severe symptoms. Over three-fourths of participants who received the medication achieved at least 75% symptom improvement within 12 weeks of starting the medication.

A phase 3 trial kicked off in March 2025 to confirm these findings. If ICP-488 continues to show strong results, it could become another oral alternative to biologics for psoriasis.

9. Biosimilars

Several biosimilars are available for treatment of plaque psoriasis in the U.S., including many for adalimumab, etanercept, and ustekinumab. Several Stelara biosimilars have also been approved over the past year or so.

Even more biosimilars for psoriasis are slated to become available in the coming years. Keep an eye out for products such as BAT2306, which is a proposed Cosentyx (secukinumab) biosimilar.

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Written by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and served as a pharmacy editor for GoodRx.

Edited by:

Mandy Armitage, MD

Mandy Armitage, MD, has combined clinical medicine with her passion for education and content development for many years. She is co-executive director at Nonclinical Physicians Network and has served as medical director for the health technology companies HealthLoop (now Get Well) and Doximity.

Reviewed by:

Maria Robinson, MD, MBA

Maria Robinson, MD, MBA, is a board-certified dermatologist and dermatopathologist who has practiced dermatology and dermatopathology for over 10 years across private practice, academic, and telehealth settings. She is a fellow of the American Academy of Dermatology and the American Society of Dermatopathology.

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